Effectiveness and safety of oral anticoagulants in non-valvular atrial fibrillation patients with prior bleeding events: a retrospective analysis of administrative claims databases

J Thromb Thrombolysis. 2022 Jul;54(1):33-46. doi: 10.1007/s11239-022-02660-2. Epub 2022 May 17.

Abstract

Introduction: There are a paucity of real-world data examining effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin in nonvalvular atrial fibrillation (NVAF) patients with prior bleeding.

Methods: This retrospective analysis included data from 5 insurance claims databases and included NVAF patients prescribed OACs with prior bleeding. One-to-one propensity score matching was conducted between NOACs and warfarin and between NOACs in each database. Cox proportional hazards models were used to evaluate the risk of stroke/systemic embolism (SE) and MB.

Results: A total of 244,563 patients (mean age 77; 50% female) with prior bleeding included 55,094 (22.5%) treated with apixaban, 12,500 (5.1%) with dabigatran, 38,246 (15.6%) with rivaroxaban, and 138,723 (56.7%) with warfarin. Apixaban (hazard ratio [HR]: 0.76 [95% CI: 0.70, 0.83]) and rivaroxaban (HR: 0.79 [95% CI: 0.71, 0.87]) had a lower risk of stroke/SE vs. warfarin. Apixaban (HR: 0.67 [95% CI: 0.64, 0.70]) and dabigatran (HR: 0.88 [95% CI: 0.81, 0.96]) had a lower risk of MB vs. warfarin. Apixaban patients had a lower risk of stroke/SE vs. dabigatran (HR: 0.70 [95% CI: 0.57, 0.86]) and rivaroxaban (HR: 0.85 [95% CI: 0.76, 0.96]) and a lower risk of MB than dabigatran (HR: 0.73 [95% CI: 0.67, 0.81]) and rivaroxaban (HR: 0.64 [95% CI: 0.61, 0.68]).

Conclusions: In this real-world analysis of a large sample of NVAF patients with prior bleeding, NOACs were associated with similar or lower risk of stroke/SE and MB vs. warfarin and variable risk of stroke/SE and MB against each other.

Keywords: Major bleed; Non-vitamin K anticoagulant; Nonvalvular atrial fibrillation; Warfarin.

MeSH terms

  • Administration, Oral
  • Aged
  • Anticoagulants / adverse effects
  • Atrial Fibrillation* / complications
  • Atrial Fibrillation* / drug therapy
  • Dabigatran / adverse effects
  • Embolism* / epidemiology
  • Embolism* / etiology
  • Embolism* / prevention & control
  • Female
  • Hemorrhage / chemically induced
  • Hemorrhage / drug therapy
  • Humans
  • Male
  • Retrospective Studies
  • Rivaroxaban / adverse effects
  • Stroke* / epidemiology
  • Stroke* / etiology
  • Stroke* / prevention & control
  • Warfarin / adverse effects

Substances

  • Anticoagulants
  • Warfarin
  • Rivaroxaban
  • Dabigatran